A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous Phase 2 And 3 EDP1815 Trials

EDP1815-208

This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815. The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.

2022-06-06

2023-05-25

2023-06-07

Terminated

Early phase I

287

Inclusion Criteria: 1. Must have provided informed consent. 2. Must have completed the treatment period in a parent study of EDP1815 in atopic dermatitis and complied with the parent protocol. 3. Must agree to use emollients. 4. Must continue to follow contraception criteria. Exclusion Criteria: 1. Participants who are currently enrolled in another investigational drug study or plans to receive another investigational drug during this study. 2. Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study. 3. Use of phototherapy, a biologic agent, or a systemic immunosuppressive agent that could affect AD, including systemic corticosteroids, within 7 days prior to Day -1, unless used as a rescue treatment as part of the parent study protocol. 4. Use of topical atopic dermatitis therapies, including topical corticosteroids, topical calcineurin inhibitors, topical PDE-4 inhibitors, and topical JAK inhibitors, within 7 days prior to enrolling in the study, unless used as a rescue treatment as part of the EDP1815-207 protocol. 5. Has received live or live-attenuated vaccination prior to enrollment or intends to have such a vaccination during the study. 6. Hypersensitivity to P histicola or to any of the excipients. 7. Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open Label Extension Study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 287, 'type': 'ACTUAL'}}

2023-09-07